L-Tryptophan, the FDA, and the Regulation of Amino Acids Carter Anne Mcgowan
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Cornell Journal of Law and Public Policy Volume 3 Article 10 Issue 2 Spring 1994 Learning the Hard Way: L-Tryptophan, the FDA, and the Regulation of Amino Acids Carter Anne McGowan Follow this and additional works at: http://scholarship.law.cornell.edu/cjlpp Part of the Law Commons Recommended Citation McGowan, Carter Anne (1994) "Learning the Hard Way: L-Tryptophan, the FDA, and the Regulation of Amino Acids," Cornell Journal of Law and Public Policy: Vol. 3: Iss. 2, Article 10. Available at: http://scholarship.law.cornell.edu/cjlpp/vol3/iss2/10 This Article is brought to you for free and open access by the Journals at Scholarship@Cornell Law: A Digital Repository. It has been accepted for inclusion in Cornell Journal of Law and Public Policy by an authorized administrator of Scholarship@Cornell Law: A Digital Repository. For more information, please contact [email protected]. LEARNING THE HARD WAY: L-TRYPTOPHAN, THE FDA, AND THE REGULATION OF AMINO ACIDS I sit before you helpless, broke, alone and in unyielding, relentless pain .... For those who have died and for those of us who live with cloudy futures, the lack of action is too little, too late. We have needed help with our orphan dis- ease. We need help now .... The U.S. Government is totally ineffective, and each agonizing day we grow more fragile. For those who appear to be in remission, we rejoice. But we cannot say with certainty that anyone is cured as long as the exact cause and cure is not found. For many of us, it is too late. We want life again.' - Frances L. Thompson, EMS Victim INTRODUCTION Reports of a mysterious, crippling illness surfaced in New Mexico during October, 1989.2 Severe muscle pain, a marked thickening of the skin, fatigue, dyspnea,3 and blood counts4 well out of the normal range inflicted previously healthy people.5 The mystery illness, eosinophilia-myalgia syndrome (EMS), today numbers over 1500 cases and thirty-eight con- 'FDA's Regulation of the Dietary Supplement L-tryptophan, 1991: Hearing Before the Human Resources and Intergovernmental Relations Subcommittee of the House Committee on Government Operations, 102d Cong., 1st Sess. 26 [hereinafter Hearing] (statement of Frances L. Thompson, EMS Victim). 2 Mary L. Kamb et al., Eosinophilia-MyalgiaSyndrome in L-tryptophan- Exposed Patients, 267 JAMA 77, 77 (1992). ' Dyspnea is an "air hunger resulting in labored or difficult breathing, sometimes accompanied by pain." TABER'S CYCLOPEDIC MEDICAL DICTIONARY 547 (Clayton L. Thomas ed., 16th ed. 1989) [hereinafter TABER'S]. 4 Specifically, afflicted people had abnormal eosinophil counts. The EMS Story, FIBROMYALGiA NETWORK: NEWSLETTER FOR FimROMYALGiA, FIBROSI- TIs/CFS SUPPORT GROUPS (Bakersfield, Cal.), Oct. 1993, at 5. An eosinophil is a type of white blood cell which "constitute[s] 1% to 3% of [the] white blood cell count." TABER'S, supra note 3, at 1020. ' The EMS Stoy, supra note 4, at 5. 383 384 CORNELL JOURNAL OF LAW AND PUBLIC POLICY [Vol.3:383 firmed deaths.6 Many of those who survive exist in states of incapacitating pain and disability.' How did this disease come about? Although initially a baffling puzzle, researchers now understand that EMS was caused by contaminated L-tryptophan.8 L-tryptophan is an amino acid which was sold as an over-the-counter dietary supplement in health food stores and pharmacies. Manufactur- ers advertised L-tryptophan as a "natural" sleep aid, a remedy for premenstrual syndrome, and a cure for depression? In reality, it was neither natural nor approved by the FDA for these proposed uses.' ° Yet it was readily available. The EMS epidemic brought about an awakening in the U.S. Government. The regulation of dietary supplements became a hot topic. Members of Congress introduced three bills in 1993 aimed at altering the standards for regulating dietary supple- ments in the Food, Drug, and Cosmetic Act." This Note examines the regulatory scheme necessary to prevent future public health threats related to dietary supple- ments, using the L-tryptophan-related EMS outbreak as an ' Regulation of Dietary Supplements, 58 Fed. Reg. 33,690, 33,690 (1993). Although the official number of cases reported is set at 1500, the National EMS Support Group alleges that EMS afflicts more than 5000 people. See Louis Jacobson, Washington Update, 25 NAT'L J. 1237, 1237 (1993). The EMS Story, supra note 4, at 5. 8 Laurence Slutsker et al., Eosinophilia-MyalgiaSyndrome Associated with Exposure to Tryptophan from a Single Manufacturer, 264 JAMA 213, 215 (1993). 9 David L. Wilson, Tracking Down a Killer, 22 NAT'L J. 2491, 2491 (1990). 10 Malcolm Gladwell, '72 Diet-PillBan Ignored Until Recent Deaths,WASH. POST, Sept. 5, 1990, at Al. Tryptophan in a bottle is not a nutritional supplement. Tryptophan in dietary protein is an important nutrient. When you have it in protein it comes along with 21 other amino acids and you need the pattern, all of them, in order to utilize them to make your own protein. When you take pure tryptophan in pills or in a bottle, it's not natural. Never in man's evolutionary history did he or she take an individual amino acid of that sort. It doesn't happen; it's not natural. Hearing, supra note 1, at 71 (statement of Richard J. Wurtman, M.D., Professor of Basic Neuroscience and Director, Clinical Research Center, Massachusetts Institute of Technology). 11 H.R. 1709, 103d Cong., 1st Sess. (1993); H.R. 2923, 103d Cong., 1st Sess. (1993); H.R. 509, 103d Cong., 1st Sess. (1993). 19941 REGULATION OF AMINO ACIDS 385 example. Part I discusses the history of government regulation of amino acids and other dietary supplements. Part II docu- ments the EMS outbreak and how its cause - contaminated L-tryptophan - was discovered. Part III discusses pertinent aspects of proposed regulatory frameworks for amino acid dietary supplements and analyzes their efficacy. Part IV exam- ines the Canadian framework for the regulation of food and drugs, which effectively insulated Canada from an outbreak of L-tryptophan related EMS. Part V proposes several alternatives for the effective regulation of amino acid dietary supplements. I. BACKGROUND A. A BRIEF OVERVIEW OF AMINO ACIDS Amino acids - components of proteins - are one of the seven materials necessary for animal life.' 2 In their natural form, amino acids result from the breakdown of proteins in the digestive process.'" Enzymes first break proteins into polypep- tides, 4 the basic structural components of protein mol- ecules.' 5 Eventually, through interaction with additional en- zymes, 6 the polypeptides break down into dipeptides and finally amino acids.'7 Amino acids then diffuse through the mucous membranes of the intestine and into the body to carry out their functions.' 8 The body uses amino acids to produce hormones such as insulin, to produce enzymes, and to produce antibodies.'9 In 12 PAUL B. WEISZ, THE SCIENCE OF BIOLOGY 447 (3d ed. 1967). The other necessary materials are water, minerals, organic carbon, organic nitrogen, vitamins, and essential fatty acids. Id. '3Id. at 454. 14 Id. These enzymes (trypsin, chymotrypsin, and pepsin) are proteinases. Id. A proteinase is "an enzyme that catalyzes the breakdown of native proteins." TABER'S, supra note 3, at 1500. 16 WEISZ, supra note 12, at 846. 16 These enzymes are called peptidases. Id. A peptidase is "an enzyme promoting the liberation of individual amino acids from a peptide, that is, an amino acid complex smaller than a whole protein." Id. 7Id. at 454. 18 Id. at 456-57. 19 THE COLUMBIA UNIVERSITY COLLEGE OF PHYSICIANS AND SURGEONS COMPLETE HOME MEDICAL GUIDE 306 (Donald F. Tapley et al. eds., rev. ed. 386 CORNELL JOURNAL OF LAW AND PUBLIC POLICY [Vol.3:383 nature, eighty amino acids exist; the human body has the capacity to produce all but eleven of these.2 ° The human diet must include all eleven of these "essential" amino acids: histi- dine, isoleucine, leucine, lysine, methionine, cystine, phenylala- nine, tyrosine, threonine, tryptophan, and valine.2' The essen- tial amino acids exist in foods as varied as milk, meat, egg whites, grains, and legumes." Amino acid deficiencies are rare in the United States because Americans consume excessive amounts of protein.23 Although health food stores carry protein and amino acid supplements, doctors state that amino acid supplements yield no proven benefits and can lead to nutritional imbalances.24 The amino acids that consumers purchase in health food stores and pharmacies are not food proteins broken down into their component amino acids; instead, health food stores sell single amino acids isolated in a way not found in nature." Amino acid supplements are available in pills and powders, and some are genetically engineered." 1989) [hereinafter COMPLETE HOME MEDICAL GUIDE]. 20 See TABER'S, supra note 3, at 74. 21 Id. at 74. The nonessential amino acids (which can be produced by the body) are alanine, aspartic acid, arginine, citruline, glutamic acid, glycine, hydroxyglutamic acid, hydroxyproline, norleucine, proline, and serine. Id. 22 COMPLETE HOME MEDICAL GUIDE, supra note 19, at 306. 23 Id. I would hasten to say that there is not a single person in America who is tryptophan deficient. It doesn't happen that you get isolated amino acid deficiencies. Hearing, supra note 1, at 71 (statement of Richard J. Wurtman, M.D., Professor of Basic Neuroscience and Director, Clinical Research Center, Massachusetts Institute of Technology). 24 COMPLETE HOME MEDICAL GUIDE, supra note 19, at 307. Genetic anomalies in amino acid metabolism are possible. These deficiencies may be in transport (in the renal tubule or gastrointestinal mucosa) or catabolic. THE MERCK MANUAL OF DIAGNOsIs AND THERAPY 2235 (Robert Berkow et al. eds., 1992). One of the best known catabolic diseases is phenylketonuria, in which the body does not correctly excrete excess phenylalanine.